APPI-Cost Trial for Perforated Appendicitis

Conditions

• Perforated Appendicitis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• PVI — DRUG
  After removal of the appendix from the patient's abdomen and attainment of hemostasis, 10 mL/kg of 1% PVI (up to a maximum of 1,000 mL) will be used to irrigate the pelvis and right upper and lower quadrants. The solution will be left to dwell for 1 minute and then suctioned out
• Usual Care — DRUG
  Surgeons may utilize local irrigation with saline if deemed necessary, defined as instillation of a small volume (\<100 mL) of liquid followed by aspiration, for the purpose of confirming hemostasis or suctioning thick fluid. Some surgeons may utilize large volume irrigation with saline solution, if that is consistent with their usual practice. Patients in the usual care arm will not receive PVI irrigation.

Study Details

The purpose of this study to assess the clinical effectiveness and cost-effectiveness of povidone-iodine (PVI) irrigation in perforated appendicitis, to investigate barriers and facilitators to future implementation of PVI irrigation, and to collect costs and clinical and patient-reported outcomes among patients with non-perforated appendicitis.

Key Dates

Start date

Apr 7, 2025

Status verified

Dec 2025

Primary completion

Jun 30, 2026

Completion

Mar 31, 2027

Study Design

Enrollment

346 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: PVI
• Active Comparator: Usual Care

Primary Outcome Measure

Cost-effectiveness of PVI relative to usual care [ Time Frame: 30 day follow up ]

Central Contacts

• Dalya M Ferguson, MD, MS
  (713) 566-5098
  [email protected]
• Debbie Nguyen
  (713) 566-5098
  [email protected]

Locations (1)

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